Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00112996 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as alpha-lipoic acid, may protect normal cells from the side effects of chemotherapy. Alpha-lipoic acid may also prevent damage to nerves that carry information to and from the brain and spinal cord to the rest of the body. It is not known whether alpha-lipoic acid is more effective than placebo in preventing peripheral neuropathy.
PURPOSE: This randomized phase III trial is studying alpha-lipoic acid to see how well it works compared to placebo in preventing peripheral neuropathy in patients receiving chemotherapy for cancer.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific |
Drug: alpha-lipoic acid Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control |
Official Title: | Prevention of Cisplatin- or Oxaliplatin-Induced Peripheral Neuropathy With Alpha-Lipoic Acid: A Placebo-Controlled Phase III Trial |
Estimated Enrollment: | 244 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Arm I: Experimental
Patients receive oral alpha-lipoic acid* three times daily for at least 24 weeks in the absence of unacceptable toxicity.
|
Drug: alpha-lipoic acid
Given orally
|
Arm II: Placebo Comparator
Patients receive oral placebo* three times daily for at least 24 weeks in the absence of unacceptable toxicity.
|
Drug: placebo
Given orally
|
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior platinum-containing treatment (yes vs no). Patients who received prior treatment are further stratified according to prior cumulative platinum exposure (cisplatin < 200 mg/m^2 or oxaliplatin < 750 mg/m^2 vs cisplatin 200-399 mg/m^2 or oxaliplatin 750-999 mg/m^2 vs cisplatin >400 mg/m^2 or oxaliplatin > 1,000 mg/m^2). Patients are randomized to 1 of 2 treatment arms.
NOTE: *In both arms, patients begin taking study drug 4 days after completion of each chemotherapy treatment and continue taking study drug until 2 days before their next scheduled chemotherapy treatment.
Patients' symptoms of peripheral neuropathy, pain, and functional tests are assessed at baseline and then at weeks 6-8, 12, 24, 36, and 48.
PROJECTED ACCRUAL: A total of 244 patients (122 per treatment arm) will be accrued for this study within 2 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arkansas | |
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center | Recruiting |
Fort Smith, Arkansas, United States, 72913 | |
Contact: Tony A. Flippin, MD 479-484-4700 tflippin@cooperclinic.com | |
United States, Indiana | |
Horizon Oncology Center | Recruiting |
Lafayette, Indiana, United States, 47905 | |
Contact: Wael A. Harb, MD 765-446-5111 wharb@thecaregroup.com | |
United States, Kansas | |
CCOP - Wichita | Recruiting |
Wichita, Kansas, United States, 67214-3882 | |
Contact: Shaker R. Dakhil, MD, FACP 316-268-5784 | |
United States, Louisiana | |
Cabrini Center for Cancer Care at Christus St. Frances Cabrini Hospital | Recruiting |
Alexandria, Louisiana, United States, 71301 | |
Contact: Hafez Al-Halawani, MD 318-561-4186 | |
United States, Michigan | |
CCOP - Kalamazoo | Recruiting |
Kalamazoo, Michigan, United States, 49007-3731 | |
Contact: Raymond S. Lord, MD 269-373-7458 rlord@wmcc.org | |
United States, Minnesota | |
CCOP - Metro-Minnesota | Recruiting |
St. Louis Park, Minnesota, United States, 55416 | |
Contact: Patrick J. Flynn, MD 612-863-8586 patrick.flynn@usoncology.com | |
United States, Missouri | |
Cancer Research for the Ozarks | Recruiting |
Springfield, Missouri, United States, 65804 | |
Contact: John W. Goodwin, MD 417-889-8099 jgoodwin@sprg.mercy.net | |
United States, Oregon | |
CCOP - Columbia River Oncology Program | Recruiting |
Portland, Oregon, United States, 97225 | |
Contact: Keith S. Lanier, MD 503-216-6260 | |
United States, Pennsylvania | |
CCOP - Main Line Health | Recruiting |
Wynnewood, Pennsylvania, United States, 19096 | |
Contact: Paul B. Gilman, MD 610-894-7854 | |
United States, South Carolina | |
CCOP - Greenville | Recruiting |
Greenville, South Carolina, United States, 29615 | |
Contact: Jeffrey K. Giguere, MD, FACP 864-241-6251 | |
United States, Texas | |
CCOP - Scott and White Hospital | Recruiting |
Temple, Texas, United States, 76508 | |
Contact: Lucas Wong, MD 254-724-7048 lwong@swmail.sw.org | |
University of Texas M.D. Anderson CCOP Research Base | Recruiting |
Houston, Texas, United States, 77030-4009 | |
Contact: Marlys Harden-Harrison, RN 713-563-0276 | |
United States, Wisconsin | |
Marshfield Clinic - Marshfield Center | Recruiting |
Marshfield, Wisconsin, United States, 54449 | |
Contact: Tarit K. Banerjee, MD, FACP 715-387-5714 |
Principal Investigator: | Ying Guo, MD, MS | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000403155, MDA-CCC-0327, MDA-2004-0728 |
Study First Received: | June 2, 2005 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00112996 |
Health Authority: | Unspecified |
neurotoxicity unspecified adult solid tumor, protocol specific unspecified childhood solid tumor, protocol specific |
Oxaliplatin Cisplatin Neuromuscular Diseases Neurotoxicity Syndromes |
Peripheral Nervous System Diseases Neurotoxicity syndromes Thioctic Acid |
Antioxidants Vitamin B Complex Molecular Mechanisms of Pharmacological Action Growth Substances Vitamins |
Physiological Effects of Drugs Nervous System Diseases Micronutrients Protective Agents Pharmacologic Actions |